Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
NCT ID: NCT01138163
Last Updated: 2017-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2010-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Docetaxel plus bavituximab 1 mg/kg
Docetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Docetaxel plus bavituximab 3 mg/kg
Docetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Docetaxel plus placebo
Docetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Interventions
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Docetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen.
* Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* Adequate hematologic, renal, and hepatic function.
* PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN.
* New York Heart Association classification I or II
Exclusion Criteria
* Known history of bleeding diathesis or coagulopathy.
* Cavitary tumors or tumors invading or abutting large blood vessels.
* Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening.
* Venous thromboembolic events within 6 months of screening.
* Ongoing therapy with oral or parenteral anticoagulants.
* Concurrent estrogens, anti-estrogens or progesterone compounds.
* Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1.
* Symptomatic or clinically active brain metastases.
* Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening.
* Grade 2 or higher peripheral neuropathy
18 Years
ALL
No
Sponsors
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Peregrine Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Ironwood Cancer and Research Center
Chandler, Arizona, United States
South Bay Hematology Oncology
Campbell, California, United States
Medical Oncology Care Associates
Orange, California, United States
American Institute of Research
Whittier, California, United States
The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Georgia Cancer Specialists, PC
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, United States
Jewish Hospital
Louisville, Kentucky, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States
Nebraska Hematology Oncology, PC
Lincoln, Nebraska, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States
Oncology/ Hematology Care, Inc
Cincinnati, Ohio, United States
Dayton Clinical Oncology Program
Dayton, Ohio, United States
Pennsylvania State Hershey Cancer Institute
Hershey, Pennsylvania, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah Hospitals and Clinics, Huntsman Cancer Institute
Salt Lake City, Utah, United States
JSC A.Gvamichava National Oncology Center
Tbilisi, , Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, , Georgia
BiBi General Hospital & Cancer Centre
Hyderabad, Andhra Pradesh, India
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India
Mahavir Cancer Sansthan
Patna, Bihar, India
O.P. Jindal Institute of Cancer & Research
Hisar, Haryana, India
Bangalore Institute of Oncology Specialty Centre
Bangalore, Karnataka, India
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India
Bharath Hospital and Institute of Oncology
Mysore, Karnataka, India
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, India
Cancer Care Clinic
Nagpur, Maharashtra, India
Shatabdi Superspecialty Hospital
Nashik, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
SMS Medical College Hospital
Jaipur, Rajasthan, India
Chhatrapati Shahuji Maharaj Medical University
Lucknow, Uttar Pradesh, India
Shanti Mukund Hospital Curie Cancer Center
Delhi, , India
All India Institute of Medical Sciences
Delhi, , India
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
Chelyabinsk, , Russia
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
Ivanovo, , Russia
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
Moscow, , Russia
State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University named after academician I.P. Pavlov of Federal Agency of Healthcare and Social Development"
Saint Petersburg, , Russia
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
Stavropol, , Russia
State Institution of Healthcare "Tula Regional Oncology Dispensary"
Tula, , Russia
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, , Russia
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
Dnipropetrovsk, , Ukraine
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
Donetsk, , Ukraine
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
Kharkiv, , Ukraine
Kyiv City Oncology Hospital, Thoracal Department
Kyiv, , Ukraine
Uzhgorod Central City Clinical Hospital, City Oncology Center
Uzhhorod, , Ukraine
Countries
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Other Identifiers
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PPHM 0902
Identifier Type: -
Identifier Source: org_study_id
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